1. Field of the Invention
The present invention relates to a device for inserting a diaphragm into the vaginal canal and into position covering the cervix. In particular, this invention relates to a device for inserting a disposable diaphragm, which has been treated with spermacidal agent, in the proper orientation and position, utilizing means to insure that sterility is preserved.
2. Description of the Prior Art
Various birth control methods have been proposed in recent years. One widely known method of birth control is the oral administration of birth control pills. This systematic suppression of conception through the use of hormones, while being effective, often has undesirable side effects on the user, particularly older women. An additional problem which has limited the complete acceptance of such contraceptive pills is the unknown long range effects of the use of such hormones on the human body.
Of more recent date, the introduction of intra-uterine devices (IUD), has provided an alternative to birth control pills. Such devices afford effective contraception without causing the undesirable side effects produced by birth control pills. However, since the IUD is permanently placed in the uterus to provide a mechanical obstacle to insemination, it may not be tolerated by the tissue and mucous membrane which surround it. Such a condition often results in the dislodgement of the IUD and/or irritation and insult to the tissue of the uterus posing a hazard to the health of the user.
It is also known to use a flexible non-permeable diaphragm usually in conjunction with a spermacidal agent as a method of contraception. The diaphragm is lodged in the vaginal canal at the base of the cervix and is retained in this position by virtue of the surrounding contractual wall tissue and the resilience of the diaphragm.
Diaphragms have met with less acceptance by potential users than would be indicated by their contraceptive effectiveness because of three problems:
1. Inconvenience of use. Diaphragms are normally used in conjunction with a spermacidal agent, either a jelly or foam. The spermacidal agent must be applied within 20 minutes of intercourse in order to have maximum effectiveness. This poses a problem for the user in that the spermacidal agent normally comes in contact with the hands and fingers leaving them greasy and requiring the users to wash their hands and/or other parts of their anatomy to remove excess quantities of this spermacidal agent after insertion of the diaphragm.
2. Sanitary problems relating to frequent insertion and removable of the diaphragm provides a source of contamination of the vaginal canal and the uterus.
3. Esthetic problems relating to storage. Diaphragms normally have useful lives of six months or longer and are used frequently during that time. After repeated use, the diaphragms tend to take on an unpleasant odor. This odor makes it inconvenient to carry the diaphragm in the users purse or handbag where it would be most readily available.
Additionally, insertion of the diaphragm is often difficult, especially if it has been coated with the spermacidal agent. It requires the user to assume awkward body positions and engage in awkward manipulation in order to properly position the diaphragm. With respect to insertion of the diaphragm, one of the problems involves the proper orientation and positioning. Such orientation and positioning of the diaphragm is necessary since insemination cannot be prevented unless the diaphragm covers the end of the cervix.
Many insertion devices or applicator instruments are known which assist in placing the diaphragm into the vaginal canal in the proper orientation and position near the cervix.
One type of device for inserting a diaphragm is described in U.S. Pat. No. 3,786,807 to Dubin. Dubin describes a disposable diaphragm and reuseable insertion-removal unit which enables the user to easily insert, position and remove the diaphragm. The diaphragm includes a magnetically attractable object embedded in absorbent material. The magnetically attractable object is attracted to or released from the tip of the insertion-removal unit. The insertion-removal unit has a magnet at the end of a plunger-rod. When the plunger-rod is advanced forward, it attracts and hold the diaphragm and when it is retracted, it releases the diaphragm.
Another known device is U.S. Pat. No. 2,141,040 to Holt which describes an applicator device which is tubular. The pessary, which is described as useful in the treatment of infections and disorders of the cervix, uterus and vagina, is placed within an open ended tube. The tube is slightly flattened in section and provided with a piston and a handle on the end thereof. The piston forces the pessary out of the tube into an appropriate position. To insure that the pessary is properly placed it is given a distinctive color on the concave side, so that the tube, which is transparent, can be inserted with the concave side uppermost.
Both of these devices are unsatisfactory in many respects. Dubin requires a specially formed and expensive diaphragm. Additionally, it requires the use of a magnetic element in the diaphragm which may be injurious or cause an infection. Additionally, sterility of the diaphragm is not insured because it is not enclosed in a chamber and must be manually positioned on the end of the applicator. Further, there is no provision for applying, in a sterile manner, a spermacidal agent nor is there provision for indicating the proper orientation of the diaphragm for insertion.
Holt suffers from many of the same deficiencies as Dubin. Holt does provide a means for indicating the proper orientation of the diaphragm, but the means is provided on the tube itself; thus, once the tube is inserted it cannot be determined whether the tube was inserted in the proper orientation or is still in the proper orientation, for the tube is within the vagina. Holt, additionally, requires a specially marked or colored diaphragm.
Both Dubin and Holt do not provide any means for determining whether the diaphragm has been completely released from the insertion device.
Of additional interest are the following U.S. Pat. Nos.:
2,008,380 to Bachmann; PA0 2,101,875 to Schleicher; PA0 2,104,275 to Schleicher; PA0 2,218,009 to Schmitz, Jr.; and PA0 2,444,672 to Prather.
All of these references describe fairly complicated gynecological instruments for insertion of a pessary, generally by someone other than the user. None of these devices provide for enclosing the pessary in a sterile manner and are generally unsuitable for use by the user of the pessary.
None of these prior art references provide an insertion device which can, in a sterile manner, insert a disposable diaphragm treated with a spermacidal agent and provide a device which indicates the proper orientation of the diaphragm and has the capability of indicating the complete release of the diaphragm from the device.